Egg allergy is common in early childhood, affecting at least one in 50 preschool children. Influenza ("'flu") vaccines contain egg protein, as the vaccine is cultured in hen's eggs. There is robust data to support the safety of influenza vaccines (containing low or negligible amounts of egg protein) in patients with egg allergy. A new influenza vaccine, known as LAIV (Live Attenuated Intranasal Vaccine) has recently been approved by a number of licensing boards and is given by a spray into the nose. This new vaccine has been available in the United States for several years and is highly effective and against influenza infection, with an excellent safety profile in children without egg allergy. However, LAIV is also grown in hen's eggs and contains egg protein, and there are NO published data on the safety of LAIV in egg-allergic children. In SNIFFLE 1 Study, 433 doses were given to 282 egg-allergic children; data is currently being analysed. The objective of this multicentre study is to further assess the safety of intranasal LAIV in egg-allergic children, in order to demonstrate that these children can safely be given the new LAIV within a primary care health environment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
779
Ulster Hospital
Belfast, Northern Ireland, United Kingdom
Royal United Hospital Bath NHS Trust
Bath, United Kingdom
Sandwell General Hospital
Birmingham, United Kingdom
Bristol Royal Hospital for Children
Bristol, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Incidence of allergic reaction to nasal influenza vaccination using a Live Attenuated Influenza Vaccine (LAIV) in egg-allergic children
Time frame: Within 2 hours of vaccine administration
Incidence of delayed symptoms up to 72 hours after nasal influenza vaccination with LAIV in egg-allergic children
Time frame: 72 hours after vaccine administration
Asthma control test
To assess for a change in asthma control (by validated questionnaire) pre and 4 weeks post LAIV immunisation.
Time frame: 4 weeks post LAIV
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Royal Hospital for Sick Children
Edinburgh, United Kingdom
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, United Kingdom
Wye Valley NHS Trust
Hereford, United Kingdom
Cambridgeshire Community Services NHS Trust (Hinchingbrooke Hospital)
Huntingdon, United Kingdom
Leeds Children's Hospital
Leeds, United Kingdom
...and 19 more locations